FDA.reportPublic FDA data

TUMARK Flex

Primary DI
04250195602183
Brand
TUMARK Flex
Company
SOMATEX Medical Technologies GmbH
Model
271570
Catalog number
271570
Published
2015-11-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250195604651PackageGS15Not in Commercial Distribution
04250195602183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250195604651042501956046514250195604651
04250195602183042501956021834250195602183

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+4930319822500info@somatex.com

Regulatory Flags#

DUNS number
341679629
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250195600806TUMARK2715502715502015-10-27
04250195600813TUMARK Professional2715602715602015-10-30
04250195600820TUMARK Professional2715652715652015-10-30
04250195600837Tuloc2716602021-10-28
04250195600844Tuloc2716612021-10-28
04250195600851Tuloc2716632021-10-28
04250195600899Lung Marker System2720122021-10-28
04250195600905Lung Marker System2720152021-10-28
04250195601605MRI Tuloc6016492021-10-28
04250195601612MRI Tuloc6016512021-10-28
04250195602046Tuloc Premium2718802021-10-28
04250195602053Tuloc Premium2718812021-10-28
04250195602060Tuloc Premium2718832021-10-28
04250195602190TUMARK Flex2715722715722015-11-03
04250195602213TUMARK Flex2715762715762015-11-03
04250195602282TUMARK Professional X-Shape2715492715492015-10-30
04250195602350Tumark MRI6015706015702015-10-30
04250195603005Q-Wire System2714632021-10-28
04250195603029Q-Wire System2714622021-10-28
04250195603036Q-Wire System2714642021-10-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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